MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA

Model Number 107754

Device Problems Loose or Intermittent Connection (1371); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report# 2916596-2018-01044.This report is being submitted as additional information.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date, approximate age of device, and device unique identifier (udi) are unknown.The mobile power unit mpu) was not returned to the manufacturer for evaluation.The provided information indicated that the exact cause of the no external power alarm was unknown and the mpu¿s serial number was not reported.Based on the log file analysis, a root cause for the no external power alarm was determined to be related to a loss of the ac power.The submitted log files contained approximately 45 days of data (dated: (b)(6) 2018 ¿ (b)(6) 2018, per the time stamps).On (b)(6) 2018 at 12:16, the rsoc voltage levels of both power cables fluctuated from the expected ~12v down to ~6.1v then to ~3.5v in approximately 2 seconds activating no external power and low battery hazard alarms.A similar incident occurred again on (b)(6) 2018 at 09:08; the rsoc voltage levels of both power cables fell from the expected ~12v down to ~4.6v activating the same alarms observed on (b)(6) 2018 at 12:16.The associated voltage levels indicated that the alarms occurred when the system controller was powered by a mobile power unit (mpu) and indicated an intermittent loss of power.The pump support was not affected and the system was supported by the backup battery during the event.On (b)(6) 2018 at 21:39, (b)(6) 2018 at 18:55, and (b)(6) 2018 at 17:29, while the patient was connected to battery power, no external power and low battery hazard alarms activated due to both power cables being disconnected at the same time from the batteries; the expected alarms were brief and cleared when the patient was connected back to power.Throughout the log file, the system controller recorded intermittent low battery hazard and power cable faults without the associated power cable disconnected being flagged (this indicates a real disconnection).The power cable disconnect alarm activated with these events as well.All of the atypical power cable disconnects occurred while the patient was connected to battery power, and did not happen while the patient was connected to the mpu.All of the atypical power cable disconnect alarms were associated with a black and white power cable fault.There were no other notable alarms active in the log file.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.Log file analysis completed by the manufacturer¿s technical services representative revealed a no external power alarm occurred due to a disruption in power to the mobile power unit.This occurred on (b)(6) 2018 at 12:16 am.It was reported that the cause of the no external power could not be determined.No additional information was provided.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8062937
• MDR Text Key: 128393212
• Report Number: 2916596-2018-04848
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 112